An Open-Label Extension Study of Multiple Subcutaneous Doses of LY2127399 in Japanese Patients With Rheumatoid Arthritis Treated With Methotrexate
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
The objective of this study is to evaluate the safety and tolerability of 48 weeks subcutaneous (SC) dosing with LY2127399 for participants who have participated in a prior LY2127399 clinical study. At the end of the 48-week treatment period, participants will participate in a 24-week follow-up period. Additional follow up after Week 72 may continue to assess B-cell recovery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
30mg/120 mg LY2127399
Participants in the 30 milligrams (mg) every 4 weeks arm of the lead-in study will receive 30 mg every 4 weeks until the safety of the 120 mg every 4 weeks dose is confirmed in the lead-in study.
干预措施: LY2127399 (Drug)
120 mg LY2127399
Participants in the 60 mg every 4 weeks, 120 mg every 4 weeks and 120 mg every 2 weeks arms of the lead-in study will receive 120 mg every 4 weeks as these participants will enroll in this study after the safety of the 120 mg every 4 weeks dose in the lead-in study is confirmed.
干预措施: LY2127399 (Drug)
结局指标
主要结局
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
时间窗: Baseline up to 72 weeks
Included are the number of participants who experienced SAEs and treatment-emergent other non-SAEs. A summary of SAEs and other non-SAEs, regardless of causality, is located in the Reported Adverse Events (AEs) module.
次要结局
- Percent Change From Baseline in CD20+ B-cell Count(Baseline and Weeks 12, 24, 36, 52, and 72)
- Percent Change From Baseline in Peripheral B-cell Subsets(Baseline and Weeks 12, 24, 36, 52, and 72)
- Percent Change From Baseline in Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibody(Baseline and Weeks 12, 24, 36, 52, and 72)
- Percent Change From Baseline in Immunoglobulins [Immunoglobulin (Ig) G, IgM, and IgA](Baseline and Weeks 12, 24, 36, 52, and 72)
- Percent Change From Baseline in Rheumatoid Factor (RF)(Baseline and Weeks 12, 24, 36, 52, and 72)
- Percent Change From Baseline in C-Reactive Protein (CRP)(Baseline and Weeks 12, 24, 36, 52, and 72)
- Percent Change From Baseline in Erythrocyte Sedimentation Rate (ESR)(Baseline and Weeks 12, 24, 36, 52, and 72)